BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXXT SPINE STRUXXURE

    MDR report key: 8949916 · Received August 29, 2019

    Report

    Report Number
    MW5089476
    Event Type
    Malfunction
    Date Received
    August 29, 2019
    Date of Event
    August 23, 2019
    Report Date
    August 28, 2019
    Manufacturer
    NEXXT SPINE LLC
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PLACED THE 510K CLEARED HARDWARE ON SPINE. THE LOCKING MECHANISM (ANTI-BACKOUT) BROKE UPON ATTEMPTING TO LOCK SCREWS TO PLATE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741888 NEXXT SPINE STRUXXURE APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ NEXXT SPINE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR